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Only a massive global deployment of an effective vaccine can end the Covid-19 pandemic in the short term. The vaccine is being rolled out in the United Kingdom and the United States. It is expected to be available in Europe imminently.
This is where things are in South Africa.
The Health Department is playing his cards very close to his chest. The department has been extremely reluctant to provide details on how a vaccination plan would work. In response to our questions, spokesperson Popo Maja said that the department does not comment on any vaccine related to Covid-19 and that “the minister will rule on this at the appropriate time.”
COVAX is key
To get vaccines rolled out around the world is COVAX, an initiative that began in April with a noble goal: “People in every corner of the world will have access to COVID-19 vaccines once they are available, regardless of his wealth. ” It is coordinated by the Global Vaccine Alliance (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization. It supports the research, development and manufacture of COVID-19 vaccines. But to do this effectively you need money.
In that sense, South Africa got off to a bad start. On November 17, it was reported that the government did not approve the Solidarity Fund to pay a deposit of R327 million to COVAX, the 15% deposit that would guarantee access to the vaccines insured through this facility. The Health Department said it was an administrative lapse and that payment would be made before December 22.
Department officials said on SABC 3’s Morning Live program on December 17 that South Africa will only receive vaccines through COVAX in the second quarter of 2021.
On December 20, City Press reported that the South African allocation of this program would cover only 3% of the population (approximately 1.7 million people) in the first half of 2021, a considerable downward adjustment from the figure for the 10% promoted by President Cyril. Ramaphosa. Even this diminished figure was not final.
COVAX has positioned itself as the only means by which poor countries could access COVID-19 vaccines that have been purchased by rich countries. In a Sept. 3 press release, GAVI CEO Dr. Seth Berkley said, “COVAX is literally a lifesaver and the only viable way to [people living in poorer countries] will have access to Covid-19 vaccines. “
The health department seems to agree. Speaking on Morning Live at SABC 3, the Deputy Director General for Health in charge of Health Regulation and Compliance, Dr. Anban Pillay, said that “we will hear from COVAX about exactly which vaccine has been assigned to South Africa.”
So far, COVAX has agreements with nine candidate vaccine manufacturers, including the University of Oxford / AstraZeneca vaccine, which appears to be safe and effective. But COVAX’s candidate vaccines do not include the high-profile Pfizer / BioNTech or Moderna vaccines, which are, to date, the only candidate vaccines to have gained regulatory approval in the US and UK.
On December 18, COVAX announced that it had reached agreements with other pharmaceutical manufacturers, including Johnson & Johnson, which is developing a vaccine that may be of interest to the South African government.
J&J vaccine
In his interview with SABC, Pillay suggested that a shortage of refrigeration infrastructure would mean that the Pfizer / BioNTech and Moderna vaccines would not be vaccines that “many developing countries could implement.” Additionally, for ideal efficacy, both vaccines require two injections given weeks apart. The same goes for the Oxford one.
“Clearly, we would be looking more for a vaccine that we could implement that could be stored at room temperature and kept in a refrigerator,” Pillay said. He also said that a single dose vaccine is ideal. He suggested that such a vaccine would go through regulatory approval in January. The only current single-dose candidate vaccine is the one being developed by Johnson & Johnson (J&J). And it is the first vaccine candidate to seek regulatory approval in South Africa.
But the company has not released any results on the safety or efficacy of the vaccine, although it is expected to be announced in January.
J&J launched the second of its phase three trials of its candidate vaccine in mid-November. The first test phase three was launched in September. (Phase three trials are the last stage of testing a new drug or vaccine, in which thousands of people are typically randomized to receive the vaccine or a placebo.)
Can Aspen make a vaccine?
South Africa’s interest in the success of the J&J vaccine is significant, especially as local pharmaceutical manufacturer Aspen has signed an agreement with J&J to manufacture its vaccine.
On November 11, Ramaphosa commented on South Africa’s ability to manufacture and package vaccines, highlighting the agreement between J&J and Aspen. Ramaphosa also said that Biovac, a partially state-owned company, was in negotiations with a vaccine manufacturer to secure the rights to make a candidate vaccine.
The details of the agreement between Aspen and J&J are vague. It appears that national production will not include the manufacture of the vaccine itself; rather, Aspen will be responsible for the last stage processing, including the packaging of the vaccine. Furthermore, it is not clear that this agreement grants South Africa any of the doses of the vaccine. There was no response to questions sent by GroundUp to J&J.
The Health Justice Initiative (HJI) has been asking the government to publish its vaccination plans, but has not received any response. Speaking to GroundUp, HJI founder Fatima Hassan said the government must explain how it will allocate limited supplies of vaccines, equitably and rationally. He is concerned that the government is not sufficiently prepared.
Will patents block access?
Despite the enormous amount of public money from various countries that has been invested in vaccines, pharmaceutical companies own or have exclusive rights to vaccines that have so far proven successful. For practical purposes, they have exclusive say in where, who, how, and for how much vaccines are made or sold. (Moderna’s CEO has suggested that his company will not enforce its patent rights to its vaccine.)
South Africa and India, with the support of more than 100 countries and organizations such as Médecins Sans Frontières, winner of the Nobel Peace Prize, have asked the World Trade Organization to suspend intellectual property rights related to Covid-19. But this proposal has been blocked by the United States, the United Kingdom, Canada and other high-income countries.
On December 8, the International Federation of Pharmaceutical Products Manufacturers and Associations (IFPMA) issued a press release condemning the proposal and any measures to weaken intellectual property regimes that could allow people from the poorest countries to access Covid vaccines. IFPMA argued that any such move “would undermine confidence in what has proven to be a well-functioning intellectual property system” and that the progress that has been made in vaccine development has only been made possible by “an ecosystem of thriving innovation, backed by intellectual property rights. “
The press release goes on to say that the end of the pandemic is a possibility due to the “contribution of millions of people who joined the clinical trials.” Ironically for people living in South Africa, thousands of whom have participated in a series of clinical trials for Covid-19 vaccines, this participation alone means nothing when it comes to access to these vaccines.
In 2001, the member countries of the World Trade Organization published the Doha Declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health, which stated that “the TRIPS Agreement does not prevent or should prevent Members from taking action to protect the public’s health. “While South Africa was one of the countries that led the way to the now 19-year-old declaration, our national patent law has yet to fully incorporate the progress made on this statement.
However, the existing patent law has provisions that would allow the government to circumvent patents in the interest of public health. Article 56 of the Patents Law allows the government to issue compulsory licenses if “the demand for the patented article in the Republic is not satisfied to an adequate extent and in reasonable terms.” This means that if a manufacturer cannot produce enough supply, it cannot stand in the way of those with capacity.
Clearly, the demand for vaccines far exceeds the supply and will do so for some time. Does South Africa have the capacity to produce a vaccine, if it grants a compulsory license or in the unlikely event that the TRIPS exemption is successful?
In an opinion piece on June 30, researchers from the NICD, Biovac and animal vaccine manufacturing companies said that South Africa has the national capacity to produce certain types of vaccines. A Nov. 19 report in Business Day quotes Biovac CEO Morena Makhoana as saying her company has the ability to make mRNA vaccines, such as those developed by Pfizer / BioNTech and Moderna.
In September, Adar Poonawalla, executive director of the Serum Institute of India, the world’s largest vaccine producer, told the Financial Times that global vaccination coverage could only be achieved by 2024, with poor countries waiting the longest for the vaccinations
It’s hard to think of a more urgent need for humanity in the short term than ending the Covid-19 pandemic. Perhaps with a concerted global effort that puts life and equality before profit and patents, Poonawalla’s pessimistic view will turn out to be wrong.
– This article originally appeared on Groundup.org.za and has been republished with permission.
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